Medication info

Empaglutine Duo Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Yellow oval film-coated tablet with a brownish tint, double convex on both sides
Packaging
10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle, 60 tablets/bottle
Approval status
Active

MFDS item code 202201361 · Approved 2022.04.04

Summary

Main use
Effectiveness in controlling blood sugar levels in Type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
Take 1 tablet twice daily. Dosage should be determined within the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg for each component. Patients with insufficient blood sugar control on metformin alone or in combination with other medications should take empagliflozin 5 mg twice daily, and if well tolerated and additional blood sugar control is needed, may increase to 10 mg or 25 mg daily.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Effectiveness in controlling blood sugar levels in Type 2 diabetes and preventing cardiovascular events

  • Type 2 diabetes with difficult blood sugar control
  • cardiovascular disease
View approved original text

This medication is used in combination with empagliflozin and metformin to improve blood sugar control in adult patients with Type 2 diabetes. It is administered as an adjunct to diet and exercise to aid in blood sugar management. In particular, in adults with Type 2 diabetes whose blood sugar is inadequately controlled and who have cardiovascular disease, professional information should be referenced considering the impact on the occurrence of cardiovascular events. This contributes to the overall improvement of blood sugar control and cardiovascular health.

How to take

Adult dose

Take 1 tablet twice daily. Dosage should be determined within the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg for each component. Patients with insufficient blood sugar control on metformin alone or in combination with other medications should take empagliflozin 5 mg twice daily, and if well tolerated and additional blood sugar control is needed, may increase to 10 mg or 25 mg daily.

Precautions

This medication is used for the treatment of diabetes and may have a rare side effect of severe lactic acidosis, so caution is needed. When used in conjunction with other diabetes medications, hypoglycemia may occur, so blood sugar changes should be closely monitored. This medication should not be used in patients with moderate to severe renal impairment or suspected acute kidney injury. Administration should be avoided in conditions such as severe infections, dehydration, cardiac dysfunction, and acute myocardial infarction. It is safer for pregnant or breastfeeding women not to take this medication. During treatment, it is recommended to regularly monitor not only blood sugar levels but also kidney and liver function, and it is advisable to keep track of vitamin B12 levels. As urinary or genital infections may increase, immediate consultation with medical staff is necessary if any infection symptoms appear. Excessive alcohol consumption, acute illnesses, and before and after surgery may require temporary discontinuation of this medication. Particularly in elderly patients or those at risk of fluid loss, caution should be exercised concerning dehydration and low blood pressure, and fluid status should be checked and managed if necessary. This medication poses a risk of hypoglycemia; therefore, when used in conjunction with insulin or sulfonylureas, dosage adjustment may be needed. If unusual symptoms such as fever, pain, swelling, skin rashes, etc., occur while taking this medication, immediate communication with healthcare personnel for appropriate measures is necessary. This medication is not recommended for children, and for the elderly, dosage should be adjusted considering kidney function. In case of overdose, there is a risk of lactic acidosis, and immediate treatment in a hospital is necessary. This medication should be stored out of reach of children and kept in its original container for safe management.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, shortness of breath, cold sweats, pallor, severe rash with high fever, blistering, skin peeling, pain in mouth/eye mucous membranes, difficulty breathing or shortness of breath, asthma attacks, respiratory irregularities associated with cough + fever, yellowing of the skin or eyes (jaundice), profound general malaise, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Nausea, vomiting, diarrhea, abdominal pain, loss of appetite, constipation, hypoglycemia, reduced vitamin B12 levels and deficiencies, altered taste, itching, rash, urticaria, erythema, increased serum lipids, increased urination, urinary difficulties, thirst, increased blood creatinine, decreased glomerular filtration rate, abnormal liver function tests, hepatitis, weakness, chest discomfort, chest pain, dizziness, headache, fever, fatigue, peripheral edema, facial swelling, swelling, weight loss,

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to ensure the effectiveness of the medication and to prevent deterioration.

Appearance and packaging

Appearance

Yellow oval film-coated tablet with a brownish tint, double convex on both sides

Package unit

10 tablets/box [10 tablets/PTP x 1], 60 tablets/box [10 tablets/PTP x 6], 30 tablets/bottle, 60 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.